Biosimilar regulations and CMOs

  WEBINAR: JUNE 26 | 11AM ET/8 AM PT Biosimilar legislation passed in 2010 guaranteed 12 years of patent protection to biotechs from biosimilar competition. But passing the law was the easy part. As FDA hashes out regulations to implement the law, we help CMOs understand the significance of the legislation to their businesses and how the new legislation may help, or hurt, contract manufacturing for biologics. Register Now! Sign up for our FREE newsletter for more news like this sent to your inbox! We won't see overall survival rate data until next year, but Genentech--a subsidiary of Roche ($RHHBY)--has been confident that it can succeed with what it already knows. Genentech has also been burnishing its reputation as a leader in the field of armed antibodies. Its T-DM1 therapy provided a fresh example at ASCO this year of how an antibody-drug conjugate can work against cancer. And Genentech's Dietmar Berger told FierceBiotech at the meeting that the company is prepping for a combination study of T-DM1 and pertuzumab.  As Xconomy notes, though, there's some fretting going on about the cost of these new combos. Herceptin isn't cheap. And adding another expensive treatment to the package may appeal to patients but cause some financial heartburn among the payer community.